Phase 3 Eczema Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Women who could become pregnant must have a negative pregnancy test at the screening visit and must agree to use highly effective contraception during the trial and for 6 months after the last dose of the study medication; men must agree to use a condom during the trial and for 3 months after the last dose, and must not donate sperm from the screening visit until at least 3 months after the last dose.
• A person must have been diagnosed with atopic dermatitis (a chronic skin condition causing itchy, inflamed skin) at least 12 months before the screening visit, using a recognised set of diagnostic standards.
• The atopic dermatitis must be moderate to severe at the baseline visit, measured by specific scoring tools used by doctors to assess the skin condition's extent, severity, and impact on daily life (confirm with trial site for exact score thresholds).
• The person must be considered eligible for whole-body (systemic) treatment, meaning there is a documented record — within the past 12 months — showing that standard skin creams or ointments did not work well enough, or that the person has already needed stronger systemic medicines for their skin condition.
• The person must have been using a moisturising skin cream or ointment at a consistent dose for at least 7 days in a row before the baseline visit.
• A chest X-ray showing no significant abnormalities must have been done within the 6 months before the baseline visit.
• The person must be able to understand and sign an informed consent form, showing they understand what the trial involves.
• The person must be willing and able to follow all trial requirements for the full duration of the study.
• The person must have health insurance coverage as required in their country.

Who may not be able to join:

• Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the trial.
• People who have previously been treated with methotrexate (MTX), the study medication being tested.
• People with a known allergy or sensitivity to methotrexate, folic acid, or any of the ingredients in the study medication.
• People who have mouth ulcers or a known active stomach or intestinal ulcer condition.
• People with known blood disorders, including low red blood cell levels, low white blood cell counts, or low platelet counts (confirm with trial site for specific thresholds).
• People with liver problems, certain abnormal liver blood test results, or a positive result on a specific liver health test called the Fibrotest at the screening visit.
• People with a history of drug or alcohol misuse in the past 12 months.
• People with reduced kidney function below a certain level (confirm with trial site).
• People with serious ongoing or long-term infections such as tuberculosis, hepatitis B, hepatitis C, HIV, or other conditions affecting the immune system — with specific rules around each infection type:
  • A positive hepatitis B surface antigen or core antibody test at screening would prevent joining; however, people with a history of hepatitis B vaccination who test positive only for surface antibodies may still be considered.
  • A confirmed positive hepatitis C test at screening would prevent joining, even if the person has previously been treated successfully for hepatitis C.
  • A positive tuberculosis blood test result may allow joining only if the tuberculosis is inactive (latent), the chest X-ray shows no signs of active tuberculosis, there are no symptoms of tuberculosis, and a documented course of specific preventive antibiotic treatment has been completed — and only after approval from a tuberculosis specialist.
• People who have had an uncontrolled infection requiring hospital admission or intravenous antibiotics within the 2 months before the baseline visit.
• People with a history of cancer, except for certain treated skin cancers or cervical pre-cancer with no recurrence in the past 5 years.
• People with other skin conditions that could interfere with assessing the atopic dermatitis, such as psoriasis or lupus affecting the skin.
• People who have taken another investigational (trial) drug within 8 weeks, or within 5 half-lives of that drug (whichever is longer), before the baseline visit.
• People who have used certain prescription skin treatments — including topical corticosteroids, calcineurin inhibitors, or phosphodiesterase-4 inhibitors — within 1 week before the baseline visit.
• People who have taken oral corticosteroids or certain other immune-suppressing medicines within 4 weeks before the baseline visit.
• People who started allergen immunotherapy (a type of treatment to reduce allergic reactions) within 3 months before the baseline visit.
• People who have received certain targeted biologic medicines (such as dupilumab or tralokinumab) within the past 3 months or 5 times the half-life of the medicine (whichever is longer), or certain JAK inhibitor medicines within the past 4 weeks before the baseline visit.
• People who have received corticosteroid injections or infusions within 6 weeks before the baseline visit.
• People who have had ultraviolet (UV) light therapy for their skin within 4 weeks before the baseline visit.
• People who have received a live vaccine within 4 weeks before the baseline visit, or who plan to receive a live vaccine during the trial.
• People who have planned surgery scheduled during the trial period.
• People with another serious medical condition that is not well controlled and that, in the investigator's opinion, could affect their ability to take part or affect the trial results.
• People with any other condition that, in the investigator's opinion, could affect safety or the assessment of results.
• People who are legally under guardianship, currently in hospital for reasons unrelated to this trial, or in a situation involving legal restrictions on participation in clinical trials.
• People currently doing mandatory military service, people who are deprived of their liberty, people legally prohibited from joining clinical trials, or people living in residential care due to age, disability, or health needs that require ongoing assisted care (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.